The watch measures beat-by-beat heart rate and oxygen saturation of arterial hemoglobin (SpO2). Caesarea, Isreal-based CardiacSense received CE mark approval for four indications for the watch in February 2021. That approval included continuous AFib monitoring and beat-by-beat pulse rate by photo-plethysmography (PPG).
CardiacSense said it plans to submit additional data to the FDA to support additional indications. It’s engaged in discussions with prospective U.S.-based commercial partners. The company expects to finalize agreements and launch CSF-3 in the U.S. in the second half of 2023.
The company conducted clinical trials demonstrating the accuracy of CSF-3’s optical sensors. They monitor cardiac arrhythmias, respiratory rate and blood pressure. CardiacSense plans to submit these data for FDA review this year.
“Motion artifacts are the key problem plaguing other PPG based systems,” said Eldad Shemesh, CardiacSense founder and CEO. “We have developed proprietary hardware, including a novel motion artifact sensor, which identify and cancel out motion artifacts thereby leaving us with a pure biometric signal for accurate vital sign monitoring.”
Additionally, Shemesh said clinical data submitted to the FDA demonstrated sensitivity and specificity of 99.6% for beat-by-beat heart rate when compared to a Holter monitor.
Another medical-grade watch enters the fray
A number of companies develop watches for all kinds of medical uses. Last month, the FDA cleared the ChroniSense Medical Polso remote patient monitoring system. That watch monitors blood oxygen saturation (SpO2), pulse rate and respiration rate.
Last summer, Masimo began the launch of its W1 health watch for consumer use. The W1 watch provides accurate, continuous measurements and insightful health data. The wrist-worn wearable builds on Masimo’s designs for non-invasive blood parameter monitoring.
Companies that develop smartwatches for consumers also entered the healthcare realm with their devices. Apple received FDA clearance for irregular heart rhythm detection and notification on its watch in November 2021. Fitbit garnered FDA clearance for AFib detection in April 2022.
Then, companies like iRhythm — much like CardiacSense — aim to supplant the traditional Holter monitor. iRhythm’s ZioXT is worn on the chest. However, it also has the Zio Watch under development. Zio Watch is a sensor-based wearable for non-invasive, clinical-grade, long-term continuous monitoring for AFib.